Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Busulfan Fresenius Kabi   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Бусулфан Fresenius Kabi (BG)
   - Busulfano Fresenius Kabi (ES)
   - BUSULFAN FRESENIUS KABI (FR)
   - Bussulfano Fresenius Kabi (PT)
Auth. number : EU/1/14/951
Active substance : busulfan
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01A - Alkylating agents
Chemical subgroup: L01AB - Alkyl sulphonates
Chemical substance: L01AB01 - Busulfan
(See WHO ATC Index)
Indication: Busulfan followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to
conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the
combination is considered the best available option.
Busulfan following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic
progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity
conditioning (RIC) regimen.
Busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning
treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Marketing Authorisation Holder: Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/09/2014 Centralised - Authorisation EMEA/H/C/2806 (2014)6865 of 22/09/2014
13/03/2015 Centralised - 2-Monthly update EMEA/H/C/2806/IB/1 (2015)1744 of 11/03/2015